Clinical news in the headlines

New results from the Women’s Health Study published last week concluded that healthy women did not reduce their risk of cancer and heart disease by taking low-dose aspirin or vitamin E.

In two studies, close to 40,000 healthy women were followed for an average of 10 years, randomly assigned to receive 100 mg of aspirin every other day with 600 IU of vitamin E on alternate days, or placebo. Researchers found no difference in incidents of cancer among those taking aspirin vs. placebo and found that Vitamin E conferred no overall benefit for cardiovascular events or cancer. The studies appeared in the July 6 Journal of the American Medical Association (JAMA).

A JAMA editorial pointed out that the results are convincing because of the heart study's large sample size and 10-year time frame. However, the results do not cancel out previous evidence that moderate to high doses of aspirin may reduce the risk of certain cancers, such as colon or colorectal, the editorial said. The authors also noted a slight beneficial effect on lung cancer among those taking aspirin.

The new findings come after another study published in the March 31 New England Journal of Medicine found that aspirin did not lower the rate of heart attacks in women, although it slightly reduced their risk of stroke, the July 6 Washington Post reported. However, another study recommended that people over age 50 take aspirin routinely to ward against cardiovascular disease, cancer and Alzheimer’s disease.

The authors noted that further trials are needed to determine whether higher doses of aspirin can protect against cancer. They concluded, however, that there is no evidence to support taking vitamin E supplements for either cancer or heart disease prevention.

Results of a recent review add to a growing body of evidence that vitamin E does not reduce the risk of death from heart disease—and may increase risk if taken in high doses.

The review included 19 randomized controlled trials where vitamin E dosages ranged between 16.5 and 2000 IU/d. Researchers found that mortality did not increase in the low-dose groups but that a dose-response relationship exists between mortality and vitamin E doses of more than 150 IU/d. Higher doses (greater than 400 IU/d) were associated with increased all-cause mortality (4% relative risk increase). The study is abstracted in the July-August ACP Journal Club.

The review is the fifth meta-analysis or review of vitamin E trials in the recent past, said the Journal Club commentator. This study is unique in that it divided the trials by dosage and illustrated that the risk of death rises with increased doses. However, the review does not apply to healthy people, the commentator added, because the trials included only those with chronic disease, or at risk for it.

Given the evidence against using vitamin E, physicians should focus on other proven strategies for reducing heart disease risk, the commentator said. Patients who continue to use vitamin E should keep the dose below 150 IU/d.

A study published last week concluded that having a low level of prostate-specific antigen (PSA) does not guarantee that a man will be disease-free.

The study involved almost 19,000 healthy men age 55 and over with a PSA level of less than 3 who received annual PSA measurements and digital rectal exams over seven years. The men underwent biopsies if their PSA rose above 4 and at the end of the study. Researchers found that some men with PSA levels of 1 had cancer while some with higher levels did not develop the disease. The study appeared in the July 6 Journal of the American Medical Association (JAMA).

Researchers noted that the standard PSA test produces many false positives and false negatives, according to the July 6 Washington Post. As a result, some men are unaware they have the disease because of their low PSA levels while others with higher levels undergo unnecessary biopsies. The findings are in line with an earlier study by the same authors, which found that as many as 15% of men with PSA levels below 4 had prostate cancer and that 15% of those were high-grade.

The results may help explain why intensive screening over the past 15 years has not had a direct impact on prostate cancer mortality, the authors said. While the death rate from prostate cancer has decreased in the United States, this could be due to better treatments, especially because the number of prostate cancer deaths has also declined in countries where PSA screening is uncommon. More tumors would be detected if biopsies were performed on men with lower PSA levels, the authors noted, but doing this would increase biopsy rates and possibly lead to unnecessary treatment of inconsequential cancers.

According to the authors, it will be a challenge for the medical community to accept that no “normal” PSA level exists. However, the results clearly indicate that there is no absolute cutoff point at which to recommend biopsy.

Managed care update

The No. 2 U.S. health insurer UnitedHealth Group Inc. made a major push into Medicare managed care and the Western states by agreeing last week to purchase PacifiCare Health Systems.

The $8.1 billion purchase would bring total national health plan membership figures for the Minnesota-based UnitedHealth to 26 million, just below No. 1 WellPoint Inc.’s 28 million members, said the July 7 San Francisco Chronicle. PacifiCare, which is based in California and has 3.3 million members in eight states, will give UnitedHealth a major presence in California—where it now has little market penetration—as well as a large Medicare managed care enrollment.

PacifiCare’s Medicare HMO, Secure Horizons, has more than 700,000 Medicare enrollees in California, Texas, Oklahoma, Washington, Oregon and Nevada, according to the July 7 New York Times. The purchase will position UnitedHealth to serve the growing ranks of Medicare beneficiaries just as the new Medicare drug coverage benefit begins in 2006. UnitedHealth has already inked a deal with drugstore chain Walgreens to offer Medicare drugs in stores and by mail, the New York Times said.

The deal is expected to close late this year or in early 2006, pending regulatory approval.

Tort reform

A controversial new study by a nonprofit consumer group found that net claims for medical malpractice paid by 15 leading insurers have remained steady over the last five years, even as net premiums have grown 120%.

The study by the New York-based Center for Justice and Democracy drew heavy criticism from the insurance industry, according to the July 7 New York Times. An executive from the Physicians Insurers Association of America (PIAA), which represents physician-owned insurance companies, said the study’s comparison of premiums vs. payouts is meaningless because insurers look at incurred losses, which also include reserves set aside for future payouts.

The PIAA executive told the New York Times that premiums have increased because claim costs have risen along with higher jury awards. Those higher awards drive up the potential cost of future claims, he said, forcing insurers to settle more cases. Industry officials added that it often takes eight to 10 years for claims to emerge, making it necessary for companies to set aside reserves.

The study reported that between 2000 and 2004, the 15 leading medical malpractice insurers collected 21 times more in premiums than they paid out in claims, the New York Times said. A study consultant quoted in the article noted that such practices have made insurance companies extremely profitable and have led to substantial increases in their stock prices.

While only 0.8% of the cases closed in 2003 were settled in favor of plaintiffs, according to PIAA data, that small number of claims drove costs, the New York Times reported. Premiums fall with liability reform, said an AMA official quoted in the article. This is why the AMA—and the College as well—are pushing for caps on noneconomic damage awards.

Experts on both sides of the debate said the study has the potential to shift some of the blame for rising premiums from trial lawyers to insurers, according to the New York Times.

Pharmaceutical news

The makers of a new heart drug aimed at African Americans has introduced a controversial pricing program that would make the drug one of the most expensive of its kind on the market.

BiDil, made by Lexington, Mass.-based NitroMed, expected to price a single pill at $1.80 when it became available in pharmacies starting July 11. That’s more than twice the price of some other heart-failure drugs and would cost patients between $5.40 and $10.80 a day, according to the July 8 New York Times.

However, NitroMed has also set up a charity program that would allow patients with no prescription drug coverage to get the drug for $25 a month and patients with incomes three times below the poverty line to receive it free of charge, the New York Times reported. That’s more generous than most other industry drug assistance programs.

Some medical experts criticized the pricing plan, especially because the drug—the first “ethnic drug” approved by the FDA—was championed by black doctors’ groups, the article said. Some physicians also expressed concern that not all eligible patients would end up getting help because drug assistance programs require doctors to send in lengthy forms.

According to the New York Times, some physicians may decide to bypass the pricing problem by separately prescribing the two generic drugs—hydralazine and isosorbide dinitrate—that make up BiDil, said the New York Times. While these drugs are not sold in the exact doses contained in BiDil, doctors could experiment with doses or split pills, the article noted. The generic versions cost less than 25 cents a pill.

The FDA approved BiDil last month based on results from the African American Heart Failure trial, which showed that the drug reduced mortality in black patients. The company has said that up to 750,000 African American patients are candidates for the drug.

ACP news

ACP applauded recently introduced Senate legislation that would create a grant program for health information technology. That program would help solo and small group practices purchase electronic health record systems and other information technology devices.

The new bill—entitled the “Better Healthcare through Information Technology Act of 2005” (S. 1355) would also mandate uniform national information technology standards and create a center within the Agency for Healthcare Research and Quality that would offer technical assistance and develop best practices for information technology use.

If passed, the legislation would also recognize decision-support software—such as the College's PIER—as qualified health information technology. The College voiced its support for the bill in a June 30 letter sent to Senate Health, Education, Labor and Pensions Committee members and signed by John Tooker, FACP, the College's Chief Executive Officer.

The letter noted, however, that the bill also includes a matching requirement that physicians participating in the proposed grant and financial assistance programs would have to provide one-third of their information technology costs. With upfront health information technology costs running between $15,000 and $30,000 per physician, Dr. Tooker wrote, that requirement would "be prohibitively expensive for many physicians in smaller practices." College leadership believes that a more effective way to encourage physicians to invest in these technologies is through an add-on to the Medicare reimbursement system, which would accommodate ongoing training and system-upkeep costs.

ACP has also come out strongly in favor of other recently introduced health information technology bills. The "Health Information Technology Act of 2005" (S. 1227) calls for the adoption of uniform health information technology standards within two years and would authorize adjusting the Medicare payment system to recognize physicians who use information technology to manage patients with chronic illnesses.

Another bill, the "Health Technology to Enhance Quality Act of 2005" (S. 1262), would increase physician reimbursement for doctors who participate in information technology networks.

And a third, the "National Health Information Incentives Act of 2005 (H.R. 747), is legislation based on ACP policy, which would offer upfront financial incentives to physicians to buy this technology. It also would build into the Medicare physician payment system an add-on code for office visits and other evaluation and management services for those physicians who augment these services with electronic health data systems, such as electronic health records.

The College has joined dozens of national medical organizations in asking senators to restore funds cut by the House of Representatives from two programs that train health care professionals. The programs train medical personnel who serve special needs populations--and are the only federal programs designed to boost the number of minorities and primary care physicians in the nation's health care workforce.

According to a July 7 letter, a bill recently passed by the House would eliminate funding for Title VII health professions programs and slash support for Title VIII nursing programs. Those programs, the letter said, now train the professionals who treat the 20% of the U.S. population who live in health professions shortage areas.

The legislation cutting Title VII and VIII funding would continue to fund community-based health centers that provide care to the under- and uninsured. Funding cuts included in the bill, however, would eliminate the money needed to train professionals to work in those health centers, the letter said. The letter was signed by ACP and close to 60 other national medical and educational organizations.

The letter urged senators to restore health professions program funding to FY 2005 levels, which included $300 million for Title VII programs and more than $150 million for Title VIII programs.

As part of the College's ongoing effort to include ACP members in the nominations process, the 2005-06 Nominations Committee solicits your recommendations to fill new Board of Regents positions that will become vacant in 2006.

The Nominations Committee is particularly interested in receiving nominations of women, ethnic minorities, international medical graduates, chairs of medicine and practicing physicians. The committee will give all nominations careful consideration.

When considering potential candidates, please keep in mind such qualifications as commitment to the College, dependability, leadership qualities and the ability to represent the College in diverse arenas. If you choose to nominate an individual, your letter of nomination should highlight these characteristics and should specify the reasons you feel your nominee is qualified for the position. Regent nominees must be ACP Masters or Fellows.

The nomination of an individual for first-term Regent must be submitted by a standard structured nominating proposal. A letter of nomination is required and should include:

A brief description of the nominee's current activities.

Special attributes the candidate would bring to the Board.

Current and previous service in College-related activities.

Service in organizations other than ACP (medical and non-medical).

A separate letter of nomination and one letter of support must be submitted for each officer candidate. New letters must be submitted each year. Letters may be submitted by mail, fax or e-mail.

A seconding letter must be submitted for each nomination. Without the appropriate material, the nomination will not be advanced for review.

Potential candidates for Regent are required to have one letter of nomination and two letters of support (the author of which will be identified by the nominator). Officer and Regent candidates must have new letters of nomination and support each year, as old letters are discarded. If candidates receive more than two letters (nomination and support), these additional letters will be discarded.

Test yourself

A 66-year-old man is evaluated for a persistent rash for 6 years' duration. The rash waxes and wanes in severity, and it becomes pruritic only after he becomes hot and sweating, such as when he mows the lawn or exercises. It has always been limited to his back and lower chest. He has never treated it. The patient is otherwise well, has no other medical problems, and takes no medication. Following a physical exam, what is the most likely diagnosis?

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